Evaluation of the efficacy and safety of a Macugen monotherapy versus Combined Therapies in the Treatment of Diabetic Retinopathy – a single centre, randomized, prospective Phase II trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009909-25-DE

Enrollment

120

Registered

2009-03-17

Start date

2009-05-05

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical condition: moderate to severe non-proliferative retinopathy with diabetic cystoid macular edema. MedDRA version: 9.1 Level: LLT Classification code 10012689 Term: Diabetic retinopathy

Interventions

Trade Name: Macugen® 0.3 mg injection solution Product Name: pegaptanib-sodium Pharmaceutical Form: Solution for injection INN or Proposed INN: pegaptanib-sodium CAS Number: 222716-86-1 Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age over 18 years of either gender, moderate to severe non proliferative diabetic retinopathy (NPDR) with diabetic cystoid macular edema, informed consent given Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of any retinal laser- or kryokoagulation, any intravitreal anti-VEGF, steroid or (core)-vitrectomy within the last 6 months, vitreoretinal traction syndrome, Myopia of >8 diopters, axial length of >26mm, and likelihood of requiring cataract surgery within the ensuing 10 months. Any history of active ocular or periocular infection, radiation to head, neck, or eye; Glycosylated hemoglobin (GHb) levels of >13%; >3 episodes of severe hypoglycemia within 3 months of study entry; >2 episodes of ketoacidosis within 1 year of baseline; or evidence of severe cardiac disease, any disease that makes it impossible to conduct the trial with the patient, pregnancy and lactation, participating in a clinical trial within the last 4 weeks, patients that cannot give informed consent themself, all contra indications for the test drugs

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objectives: evaluation of improvement for the best-corrected visual acuity (BCVA) measured by EDTRS charts;Secondary Objective: Secondary objectives: evaluation of the development of retinal thickness, ocular neovascularization, change in visual quality (objective and subjective) and evaluation of Adverse Events. ;Primary end point(s): Development of the best corrected visual acuity (according to EDTRS) after 56 weeks Change in retinal thickness, ocular neovasculation and visual quality	—

Measure

Time frame

Main Objective: Primary objectives: evaluation of improvement for the best-corrected visual acuity (BCVA) measured by EDTRS charts;Secondary Objective: Secondary objectives: evaluation of the development of retinal thickness, ocular neovascularization, change in visual quality (objective and subjective) and evaluation of Adverse Events. ;Primary end point(s): Development of the best corrected visual acuity (according to EDTRS) after 56 weeks Change in retinal thickness, ocular neovasculation and visual quality

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026